The Hatch-Waxman Act: Recent Amendments and Developments
The Hatch-Waxman Act is one of the most important regulators of competition between brand and generic pharmaceutical companies. Because of its provisions, the pharma industry has continuously achieved balance when it comes to patent protection and entry of a new drug. By requiring the abbreviated new drug application (ANDA) process, Hatch-Waxman regulates the approval of a "bioequivalent" generic drug while protecting the patent rights of an existing brand drug.
Because of its significant impact on both brand and generic drug companies, it is imperative for the pharma industry to keep abreast of the latest developments in Hatch-Waxman Act: amendments, as well as potential changes in the year ahead.
Join a panel of key thought leaders and practitioners assembled by The Knowledge Group as they bring the audience to a road beyond the basics of the Hatch-Waxman Act. Listen as they delve into an in-depth analysis of the latest developments and trends involving FDA applications -- approvals and rejections. Speakers will also provide the audience with practical strategies when it comes to ANDA litigation.
This LIVE webcast will discuss the following key topics:
- The Hatch-Waxman Act: Overview and Legal Framework
- Latest Developments
- The Abbreviated New Drug Application (ANDA) Process
- Latest Developments in ANDA Litigation
- Recent FDA Applications
- The Hatch-Waxman Act in 2018 - An Outlook
Mark T. Deming, Shareholder
- Inter Partes Review in Hatch-Waxman Cases
- Key Stats
- Update on Oil States v. Greene’s Energy Group
- Update on Venue in Hatch-Waxman Cases
- Key Stats
- Application of TC Heartland
Martin B. Pavane, Vice Chair, Intellectual Property Department, Co-Chair, ANDA & Biologics Practice Group
Federal Circuit Decisions
- Infringement and Section 112 Issues
Joseph Reisman, Partner
Knobbe Martens Olson & Bear LLP
- Recent Applications of Anticipation and Obviousness Law in Hatch-Waxman Cases
- The On Sale Bar as applied under A.I.A. and pre-A.I.A. Versions of 35 U.S.C. § 102
- Limitations on the Emerging Role of Inherency in Obviousness Determinations
- Developments in the Lead Compound/Obviousness Analyses for Compounds
- The Role of Objective Indicia in an Analysis of Obviousness
Who Should Attend:
- Healthcare Law Attorneys
- FDA Attorneys
- In-house Counsel
- Patent Law Counsel
- Biotech/Pharma Industry Lawyers
- Drug Manufacturing Executives
- Health Industry Advisors
Mark is shareholder in Polsinelli’s Hatch-Waxman litigation group. Mark’s practice involves the representation of both brand and generic pharmaceutical companies. He is involved in all aspects of case developments, from initial assessment to discovery, motions practice, claim construction, expert witnesses, trial and appeal. Polsinelli’s Hatch-Waxman team represents some of the world’s largest and most influential generic, brand, and specialty pharmaceutical companies. They have litigated a broad variety of drug products, many in first-to-file cases as well as in subsequent-filer cases, and have first-chair experience litigating Hatch-Waxman cases in key venues, including Delaware, New Jersey, and the Eastern District of Texas. Their knowledge of the pharmaceutical sciences includes compositions and APIs, formulations (oral dosage forms, controlled release, ODTs, transdermal, topical, ophthalmic, transmucosal, parenteral, etc.), methods of use, polymorphs, enantiomers, drug delivery devices, and methods of manufacture.
Mark is shareholder in Polsinelli’s Hatch-Waxman litigation group. Mark’s practice involves the representation of both brand and generic pharmaceutical companies. …
Martin B. Pavane, Vice Chair of Cozen O’Connor’s Intellectual Property Department, is a litigator and registered patent attorney with more than 30 years of experience litigating intellectual property cases. He has been lead trial counsel in many patent, trademark and copyright cases throughout the United States, including many jury trials. At Cozen O’Connor, Martin currently holds the titles of vice chair of the Intellectual Property practice group and co-chair of the ANDA and Biologics practice group, and he is also on the Board of Directors of the firm. He has been named a New York Super Lawyer in intellectual property litigation since the inception of that designation. During the early part of his career, Martin practiced extensively before the U.S. Patent and Trademark Office, where he prosecuted patent applications and handled appeals before the Board of Patent Appeals and Interferences.
Martin B. Pavane, Vice Chair of Cozen O’Connor’s Intellectual Property Department, is a litigator and registered patent attorney with more …
Joseph Reisman is a partner in Knobbe Martens’ San Diego office. He obtained a B.S. and a Ph.D. in Chemistry at, respectively, Yale University and the University of California (San Diego), and a J.D. at the University of California (Berkeley). He served as a Law Clerk to Alan D. Lourie of the Court of Appeals for the Federal Circuit. His practice involves patent prosecution and strategic counseling for pharmaceutical clients, developing and enforcing patent portfolios. He has also served as counsel for numerous generic pharmaceutical manufacturers, and has been instrumental in developing and implementing strategies for achieving early market entry of numerous generic products including atorvastatin (Lipitor) an valganciclovir (Valcyte). He serves as an adjunct professor at the University of San Diego and is a member of the Board of Directors of the Federal Circuit Bar Association.
Joseph Reisman is a partner in Knobbe Martens’ San Diego office. He obtained a B.S. and a Ph.D. in Chemistry …
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Method of Presentation:
Basic knowledge of the Hatch-Waxman Act
NY Category of CLE Credit:
Areas of Professional Practice
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Polsinelli is an Am Law 100 firm with more than 800 attorneys in 19 offices, serving corporations, institutions, and entrepreneurs nationally. Ranked in the top five percent of law firms for client service*, the firm has risen more than 100 spots in Am Law's annual firm ranking over the past six years. Polsinelli attorneys provide practical legal counsel infused with business insight, and focus on health care, financial services, real estate, intellectual property, mid-market corporate, and business litigation. Polsinelli attorneys have depth of experience in 100 service areas and 70 industries. The firm can be found online at www.polsinelli.com. Polsinelli PC. In California, Polsinelli LLP.
About Cozen O'Connor
Established in 1970 and ranked among the top 100 law firms in America, Cozen O’Connor has more than 650 attorneys who help clients manage risk and make better business decisions. The firm counsels clients on their most sophisticated legal matters in all areas of the law, including litigation, corporate and regulatory law. Representing a broad array of leading global corporations and middle market companies, Cozen O’Connor services its clients’ needs through 25 offices across two continents.
About Knobbe Martens Olson & Bear LLP
Knobbe Martens is an agent of innovation, with offices across California, as well as in New York, Seattle, and Washington, D.C. We provide clients worldwide with forward-focused Intellectual Property and Technology law service and representation. Knobbe Martens is one of the world’s largest Intellectual Property law firms, with more than 300 attorneys and scientists representing the complete spectrum of technologies and Intellectual Property practice areas. We combine unmatched technical and litigation expertise to deliver superior results in both transactional and contested matters, for both cutting edge start-ups and established Fortune 500 companies, in fields ranging from physics to pharmaceuticals and entertainment to engineering. For more information, please visit knobbe.com.